Varia-NCI is a stand-alone software accessory to a Transcranial Doppler Ultrasound device (TCD) that retrieves, analyzes, and displays Cerebral Blood Flow velocity (CBFv) data from a Transcranial Doppler Ultrasound device. Varia-NCI uses CBFv data to measure the variability of a patient's cerebral blood flow velocity.

Varia-NCI is to be used by clinicians managing head trauma in the ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine Settings.

Device Description

Varia-NCI is a stand-alone software accessory to a Transcranial Doppler Ultrasound device (TCD) that retrieves, analyzes, stores, and displays Cerebral Blood Flow velocity (CBFv) data from a Transcranial Doppler Ultrasound device. Varia-NCI uses CBFv data to measure the variability of a patient's cerebral blood flow velocity. Varia-NCI accesses data from Compumedics Germany QL 3.0 software. QL 3.0 is a trade mark of PC-based software supplied by Compumedics Germany, GmbH and included with their digital Transcranial Doppler (TCD) Ultrasound device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a device named Varia-NCI. However, it does not include a detailed acceptance criteria table, nor a study proving the device meets specific performance criteria in the way typically required for AI/ML-based diagnostic devices (e.g., sensitivity, specificity, AUC).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Compumedics Germany – Doppler-Box X) largely through non-clinical software testing and the absence of clinical testing requirements given its role as a software accessory and the established safety and effectiveness of the predicate.

Based on the provided information, here's a breakdown of what can be extracted and what is missing concerning your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a list of non-clinical software tests performed and their outcomes, indicating that the device "passed" each test. It does not provide quantitative performance metrics (e.g., accuracy, sensitivity, specificity) against specific numerical acceptance criteria.

Acceptance Criteria (Stated as Test Passed)	Reported Device Performance (Outcome)
System Integration Multiprocessing testing	Passed
System Integration - Timing and Memory Allocation	Passed
User Interface Module	Passed (including display of patient info, CBFv variability, export to CSV)
Patient Data testing	Passed (including entering, recalling, and verifying CBFv exp files and patient name)
Calculation Testing and Display results	Passed (CBFv variability calculated and displayed as numeric value and chart)
Save results Testing	Passed
System Verification/Validation Performance Testing	Passed
Labeling - User Manual Verification/Validation	Passed
Manufacturing	Passed (verify documentation, software files, build process, library installation, compilation, BOM review)

2. Sample size used for the test set and the data provenance

The document details non-clinical software testing. It does not specify a "test set" in the context of clinical data or patient samples. The testing appears to have been performed using simulated or representative data relevant to software functions (e.g., "CBFv exp files were entered into the database"). Therefore, information regarding data provenance (country of origin, retrospective/prospective) is not applicable as described for a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The testing described is software functionality testing, not a clinical study requiring expert-established ground truth on patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring expert adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study or any study involving human readers and AI assistance. The device is a software accessory that processes and displays data, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The software testing described is a form of standalone performance evaluation for the algorithm's functions. The "Test Passed" outcomes for "Calculation Testing and Display results" and "System Verification/Validation Performance Testing" demonstrate the algorithm's ability to accurately calculate and display CBFv variability. However, these are functional tests, not a clinical performance study using patient outcomes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the software testing, the "ground truth" implicitly refers to the expected behavior and correct outputs of the software's functions, as defined by its specifications. For instance, in "Calculation Testing," the ground truth would be the accurately pre-computed or theoretically expected variability values against which the software's calculations were validated. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. The document does not describe an AI/ML model that requires a training set in the conventional sense. Varia-NCI is described as software that "retrieves, analyzes, and displays Cerebral Blood Flow velocity (CBFv) data" and "uses CBFv data to measure the variability of a patient's cerebral blood flow velocity." This implies deterministic algorithms rather than a machine learning model that would be "trained."

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for an AI/ML model.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that overlap and create a sense of movement.

November 19, 2014

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

NeuroChaos Solutions, Inc. % Ms. Elisa Maldonado-Holmertz Consultant Obelix Consulting, LLC 12416 Fairfax Ridge Place AUSTIN TX 78738

Re: K141462 Trade/Device Name: Varia-NCI Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN Dated: October 16, 2014 Received: October 21, 2014

Dear Ms. Maldonado-Holmertz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141462

Device Name

Varia-NCI

Indications for Use (Describe)

Varia-NCI is to be used by clinicians managing head trauma in the ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine Settings.

Type of Use (Select one or both, as applicable)

XPrescription Use (Part 21 CFR 801 Subpart D)

□Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for NeuroChaos Solutions. The logo features a stylized, abstract graphic to the left of the company name. The text "NeuroChaos" is in a bold, sans-serif font, with the word "SOLUTIONS" appearing in smaller letters below it.

Section 5 – 510(k) Cover Letter

510(k) Summary

Varia-NCI

1. Submission Sponsor

NeuroChaos Solutions, Inc. 2645 Creeks Edge Parkway Austin, TX 78733 USA Contact: Patrick Kothe, CEO Phone: 512.426.5772 Email: pkothe@neurochaos.com

2. Submission Correspondent

Obelix Consulting, LLC 12416 Fairfax Ridge Place Austin, TX 78738 USA Contact: Elisa Maldonado-Holmertz, Consultant Phone: 512.431.6069 Email: elisamh@obelixconsult.com

3. Date Prepared

30 May 2014

4. Device Identification

Trade/Proprietary Name:	NeuroChaos Solutions, System 1.0
Common/Usual Name:	Accessory to Transcranial Doppler
Classification Name:	Ultrasonic pulsed Doppler imaging system
Classification Regulation:	CRF 892.1550
Product Code:	IYN
Device Class:	Class II
Classification Panel:	Radiology

5. Legally Marketed Predicate Device(s)

Compumedics Germany – Doppler-Box X (K051085)

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Image /page/4/Picture/0 description: The image shows the logo for NeuroChaos Solutions. The logo consists of a stylized, abstract symbol to the left of the text "NeuroChaos" in a bold, sans-serif font. Below "NeuroChaos" is the word "SOLUTIONS" in a smaller, lighter font. The overall design is clean and professional.

6. Device Description

Varia-NCI accesses data from Compumedics Germany QL 3.0 software. QL 3.0 is a trade mark of PC-based software supplied by Compumedics Germany, GmbH and included with their digital Transcranial Doppler (TCD) Ultrasound device.

7. Indication for Use Statement

Varia-NCI is an accessory to a Transcranial Doppler Ultrasound device (TCD) that collects, analyzes, stores, and displays Cerebral Blood Flow velocity (CBFv) data. Varia-NCl uses CBFv data to measure the variability of a patient's cerebral blood flow velocity.

Varia-NCI is to be used by clinicians managing head trauma in the ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine Settings.

8. Substantial Equivalence Discussion

The following table compares the Varia-NCI to the predicate device with respect to indications for use, intended use, and principles of operation for the determination of substantial equivalence.

Manufacturer	NeuroChaos Solutions, Inc.	Compumedics Germany, GmbH
Trade Name	Varia-NCI	Doppler-Box X
510(k) Number	--	K051085
Product Code	IYN	IYN and ITX
Regulation Number	892.1550	892.1550892.1570
Regulation Name	Ultrasonic pulsed Doppler imaging system	Ultrasonic pulsed Doppler imaging system
Indications for Use	Varia-NCI is a stand-alone software accessory to aTranscranial Doppler Ultrasound device (TCD) that retrieves, analyzes, stores, and displaysCerebral Blood Flow velocity (CBFv) data from a TranscranialDoppler Ultrasound device.Varia-NCI uses CBFv data to measure the variability of apatient's cerebral blood flow velocity.Vari-NCI is to be used byclinicians managing head trauma	The Doppler-Box is a medicalultrasound device for measuringthe blood flow velocities in arteriesand veins mainly subcutaneously.The 16MHz probe can also be usedintraoperative.

Table 5A - Comparison of Characteristics

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Manufacturer	NeuroChaos Solutions, Inc.in the ICU, Surgical Unit,Emergency Department, andClinical and Sports MedicineSettings.	Compumedics Germany, GmbH
Predicate	Compumedics Germany GmbHDoppler-Box X	Spencer Technologies; TCD 100M,PWD13 TRANSDUCER K002533CompumedicsDWL ElektronischeSysteme GmbH; Multi-Dop XK931801
SignificantDifferences	Stand-alone software accessoryto a Transcranial Doppler	Digital Doppler sonography system.HD resolution in Doppler M-Modepermits more precise insonation.The innovative hardware designwith no integrated computer, butwith the possibility to connect to allstandard Windows©-basedcomputer systems

9. Non-Clinical Performance Data

A test report was generated consisting of Test Description, Test Date, Tester Name, Test Criteria, Test Setup, Pass Fail Criteria, and Test Data Files. The report indicates that the software passed the test.

The following software testing has been performed to support substantial equivalence:

System Integration Multiprocessing testing : Test Passed ●
. System Integration - Timing and Memory Allocation : Test Passed
User Interface Module : Test Passed ●
- Single Patient Module Patient information needs to be displayed. O
- O User interface needs to display CBFv variability values and chart
- The system needs to export results in csv format O
- Patient Data testing o
  - CBFv exp files were entered into the database
  - Patient name was entered into the database
  - . Patient was recalled and verified that the data was the correct file
Calculation Testing and Display results : Test Passed
- The variability of CBFv was calculated and displayed as o numeric value and as a chart
Save results Testing : Test Passed
- Test results were successfully saved using Save button O

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Image /page/6/Picture/0 description: The image contains the logo for NeuroChaos Solutions. The logo features a stylized graphic to the left of the company name. The text "NeuroChaos" is in a bold, sans-serif font, with the word "SOLUTIONS" appearing in a smaller font size below it.

System Verification/Validation Performance Testing : Test Passed ●
Labeling - User Manual Verification/Validation : Test Passed
Manufacturing : Test Passed
- o Verify that all manufacturing documentation is released
- o All software files checked into VNS Software repository
- o Ran through the software build process and built the package on a clean machine with Delphi XE2 installed.
  - l Installed libraries as directed in Build Process
  - . Installed
    - -ExpressQuantumGrid
    - -ExpressBars
    - -ExpressNavBar
    - -DBSAM
Installed application software
. Run Delphi and Install supplied
- application libraries Hyperclass,

HyperDSP, ECG, and Miracle:

Open Menu: File/Open... Name of the libraryD7.dpk
Compiled Software
Reviewed BOM and Software Package

Varia-NCI is not required to conduct sterilization, biocompatibility, or electrical testing as a standalone software accessory.

As part of demonstrating safety and effectiveness, Varia-NCI shows substantial equivalence as an accessory to the predicate device that is subject to this 510(k) submission. Varia-NCI complies with the applicable Software standards.

10. Clinical Performance Data

No clinical testing is required because the device's indication for use does not substantiate the need for clinical data to support equivalency to the predicate device. The predicate device has been on the market for nearly 10 years with proven safety and effectiveness. The non-clinical testing detailed in this submission confirms the safety and effectiveness of the Varia-NCI.

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Image /page/7/Picture/0 description: The image shows the logo for NeuroChaos Solutions. The logo features a stylized, abstract graphic to the left of the text. The text "NeuroChaos" is in a bold, sans-serif font, with the word "SOLUTIONS" in a smaller font size underneath. The colors used in the logo are shades of blue.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same operational characteristics as the previously cleared predicate device, or the device has the same intended use and different operational characteristics in which substantial equivalency can be demonstrated in the device in comparison to the predicate device. Additionally, the new device does not raise new questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between Varia-NCI and the predicate device does not raise any questions regarding its safety and effectiveness. Varia-NCI, as designed and produced, is determined to be substantially equivalent as an accessory to the referenced predicate device.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.